Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial)
Authors' conclusion
In IMPROVE-IT, the benefit of adding ezetimibe to statin was enhanced in patients with DM and in high-risk patients without DM.
Study context
- Population
- Patients after ACS with LDL-C 50 to 125 mg/dL, stratified by diabetes mellitus (DM)4,933 (27%) with DM
- Participants
- 18,144 patients
- Comparison
- Ezetimibe/simvastatin vs placebo/simvastatin, by DM status
- Primary endpoint
- CV death, major coronary events and stroke
- Follow-up
- 7 years
Methodological detailsprespecified subgroup analysis
- Prespecified subgroup analysis
Primary result
As reported in the abstract
Primary end point, by DM (subgroups)
E/S vs Placebo/simvastatinHazard ratio (95% CI)
DM; absolute reduction 5.5%
0.85(0.78–0.94)
No DM; absolute difference 0.7%
0.98(0.91–1.04)
Further findings
Median time-weighted average LDL-C, by DM
- DM: E/S vs placebo/simvastatin, mg/dL
- 49 versus 67
- No DM: E/S vs placebo/simvastatin, mg/dL
- 55 versus 71
- Both P<0.001
Relative reductions in DM
- MI relative reduction
- 24%
- Ischemic stroke relative reduction
- 39%
Primary end point, by age and DM (subgroup)
- Age ≥75 y: relative reduction regardless of DM
- 20%
- Age <75 y: greater benefit with DM than without
- Interaction P=0.91 (≥75 y)
- Interaction P=0.011 (<75 y)
CV death, MI and ischemic stroke, by TIMI Risk Score for Secondary Prevention (subgroup)
- No DM, high risk: relative reduction with E/S
- 18%
- DM: benefit with E/S regardless of risk
- No DM, low or moderate risk: no benefit
- Interaction P=0.034
Safety
Safety outcomes
- No differences by treatment regardless of DM
Original publication
Benefit of Adding Ezetimibe to Statin Therapy on Cardiovascular Outcomes and Safety in Patients With Versus Without Diabetes Mellitus: Results From IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Circulation. Published 20 December 2017. doi:10.
Summarised from the published abstract; every number is checked against it